BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 18247532 · Received December 1, 2023

    Report

    Report Number
    1810909-2023-00255
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 13, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003733901
    PMA / PMN Number
    K210687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR NEXT ONE METER AND IN-HOUSE CONTOUR NEXT TEST STRIPS FROM LOT # 2MPEG08A USING BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE MODEL # (D4) WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D4 (MODEL #, CATALOG # AND UDI #) AND G4 (510K #) HAVE BEEN UPDATED. CONTOUR® NEXT TEST STRIPS WITH SKU # 7339, 510K # K210687 AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM UNITED KINGDOM REPORTED THAT WITHIN 5 MINUTES SHE OBTAINED BLOOD GLUCOSE READINGS OF 31.7 MMOL/L, 7.4 MMOL/L, 11.7 MMOL/L, 17.5 MMOL/L, AND 8.1 MMOL/L WITH THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540213 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7339 2MPEG08A 05016003733901

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female